MAUDE Adverse Event Report: LASER EYE SAFETY GLASSES; SHIELD, EYE, RADIATION

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Respiratory Distress (2045); Cramp(s) (2193); Reaction (2414); Ambulation Difficulties (2544); Chemical Exposure (2570)

Event Date 05/02/2018

Event Type  Injury  

Event Description

I ordered eye protection from amazon for use with laser lights.When i opened the package the toxic chemicals, from which the glasses and case were made, caused an immediate and severe reaction.My lower body cramped so severely i was unable to walk.I had breathing problems.Right now i have a severe headache.I was exposed for less than 3 mins.It took about 20 mins for the cramps to subside.I will place the products in a plastic bag.The product was manufactured in (b)(4) and i think it should be analyzed for toxicity, but i do not know where to take it.I would like to know where to take this product to be analyzed.I have filed a complaint with both amazon and the distributor.The name of the product is hde eye safety laser protection glasses.The distributor is hde."is the product over-the-counter: yes, strength: toxic materials, did the problem stop after the person reduced the dose or stopped taking or using the product: yes, did the problem return if the person started taking or using the product again: yes, how was it used: protects eyes material toxic." date the person first started taking or using the product: (b)(6) 2018, date the person stopped taking or using the product: (b)(6) 2018.Reason for use: to protect eyes from acne laser for skin.

• Brand Name: LASER EYE SAFETY GLASSES
• Type of Device: SHIELD, EYE, RADIATION
• MDR Report Key: 7494382
• MDR Text Key: 107797168
• Report Number: MW5077077
• Device Sequence Number: 1
• Product Code: IWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 64 YR
• Patient Weight: 131